TABLE 1.

Disposition of subjects by treatment group in the randomized population

Group	n (%) in treatment groupa
	250 mg REL + IMI	125 mg REL + IMI	Placebo + IMI	Total
Randomizedb	118	116	117	351
Treated with any study therapy	117 (99.2)	114 (98.3)	116 (99.1)	347 (98.9)
Completed study medication	112 (94.9)	107 (92.2)	111 (94.9)	330 (94.0)
Discontinued study medication because of:	5 (4.2)	7 (6.0)	5 (4.3)	17 (4.8)
Adverse event	1 (0.8)	4 (3.4)	3 (2.6)	8 (2.3)
Death	0 (0.0)	1 (0.9)	0 (0.0)	1 (0.3)
Lack of efficacy	0 (0.0)	0 (0.0)	1 (0.9)	1 (0.3)
Lost to follow-up	0 (0.0)	0 (0.0)	1 (0.9)	1 (0.3)
Physician decision	0 (0.0)	2 (1.7)	0 (0.0)	2 (0.6)
Protocol violation	2 (1.7)	0 (0.0)	0 (0.0)	2 (0.6)
Insufficient drug supply	1 (0.8)	0 (0.0)	0 (0.0)	1 (0.3)
Withdrawal by subject	1 (0.8)	0 (0.0)	0 (0.0)	1 (0.3)
Completed study	114 (96.6)	109 (94.0)	114 (97.4)	337 (96.0)
Discontinued from study because of:	4 (3.4)	7 (6.0)	3 (2.6)	14 (4.0)
Adverse event	0 (0.0)	2 (1.7)	0 (0.0)	2 (0.6)
Death	0 (0.0)	1 (0.9)	0 (0.0)	1 (0.3)
Lost to follow-up	0 (0.0)	1 (0.9)	2 (1.7)	3 (0.9)
Progressive disease	0 (0.0)	1 (0.9)	0 (0.0)	1 (0.3)
Protocol violation	3 (2.5)	1 (0.9)	0 (0.0)	4 (1.1)
Insufficient drug supply	1 (0.8)	0 (0.0)	0 (0.0)	1 (0.3)
Withdrawal by subject	0 (0.0)	1 (0.9)	1 (0.9)	2 (0.6)

^aREL, relebactam; IMI, 500 mg imipenem-cilastatin.

^bPercentages are based on the number of subjects randomized as the denominator.